Gain Therapeutics(GANX) - 2025 Q3 - Quarterly Results

Financial Performance - Gain Therapeutics reported a net loss of $0.15 per share for Q3 2025, an improvement from a loss of $0.17 per share in Q3 2024[11] - Net loss for Q3 2025 was $5,284,373, compared to a net loss of $4,485,692 in Q3 2024, representing a 17.8% increase in losses year-over-year[22] - Net loss per share attributable to common stockholders for Q3 2025 was $(0.15), compared to $(0.17) in Q3 2024[22] - The company reported a loss before income tax of $4,735,085 for Q3 2025, compared to $4,474,698 in Q3 2024[22] Expenses - Research and Development (R&D) expenses increased by $0.2 million to $2.8 million in Q3 2025, compared to $2.6 million in Q3 2024, primarily due to ongoing Phase 1b clinical trial costs[9] - General and Administrative (G&A) expenses rose by $0.1 million to $1.9 million for Q3 2025, attributed to higher stock-based compensation and personnel costs[10] - Total operating expenses for Q3 2025 were $4,785,777, an increase of 7.3% compared to $4,458,964 in Q3 2024[22] - Research and development expenses for the nine months ended September 30, 2025, were $7,865,493, down 17.8% from $9,566,259 in the same period of 2024[22] Clinical Trials - The Phase 1b study for GT-02287 in Parkinson's disease exceeded its enrollment target, with 21 participants enrolled, surpassing the original target of 15[8] - Approximately 80% of participants in the Phase 1b study expressed interest in continuing into the study extension phase[2] - Initial clinical data presented indicated a disease-slowing effect of GT-02287, with improvements in Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) scores observed after 90 days of dosing[8] - The company received approval from Australian health authorities to extend the Phase 1b study duration to a total of 12 months[8] - The analysis of functional changes and biomarker activity from the Phase 1b study is expected to be available in Q4 2025[3] - An IND submission to the FDA is anticipated by the end of 2025 to facilitate expansion into Phase 2 clinical development of GT-02287[8] Financial Position - Cash and cash equivalents were reported at $8.8 million as of September 30, 2025, down from $10.4 million as of December 31, 2024[11] - Cash and cash equivalents as of September 30, 2025, were $8,807,353, a decrease from $10,385,863 as of December 31, 2024[24] - Total assets decreased to $10,971,680 as of September 30, 2025, from $12,123,884 as of December 31, 2024[24] - Total liabilities increased to $5,062,250 as of September 30, 2025, compared to $4,784,310 as of December 31, 2024[24] - The accumulated deficit as of September 30, 2025, was $81,194,908, up from $60,783,717 as of December 31, 2024[24] Stock Information - Weighted average common stock outstanding for Q3 2025 was 34,998,060, an increase from 26,531,747 in Q3 2024[22]